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FDA 510(k)

CD-100 CARDIAC MONITOR

K-Number: K854041 · 1986-01-07

ApplicantCardio Display Corp.
Decision Date1986-01-07
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CD-100 CARDIAC MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Cardio Display Corp.. It received FDA 510(k) clearance on 1986-01-07 under 510(k) number K854041. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CD-100 CARDIAC MONITOR?

CD-100 CARDIAC MONITOR is a medical device that received FDA 510(k) clearance on 1986-01-07. The listed applicant is Cardio Display Corp.. The 510(k) number is K854041.

When did CD-100 CARDIAC MONITOR receive FDA 510(k) clearance?

CD-100 CARDIAC MONITOR received FDA 510(k) clearance on 1986-01-07, under 510(k) number K854041.

Who is the listed applicant for CD-100 CARDIAC MONITOR?

The FDA 510(k) record lists Cardio Display Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CD-100 CARDIAC MONITOR?

The FDA product code for CD-100 CARDIAC MONITOR is DRT.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Cardio Display Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K860175CD-200 CARDIAC MONITOR

Related Devices (Code: DRT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254058DistaSense(TM) (v1)Life Detection TechnologiesK261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AGK251364Sleepiz One+ (2.5)Sleepiz AGK234003The Circadia C200 SystemCircadia Technologies, Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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